An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels
NCT ID: NCT02052986
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Vascazen
Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.
VASCAZEN
All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA
Interventions
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VASCAZEN
All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA
Eligibility Criteria
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Inclusion Criteria
* Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
* Has had cardiovascular examination within the past 2 months
Exclusion Criteria
* Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
* Subjects with a known bleeding or clotting disorder
* Subjects with known allergies to fish
* Subjects with an implantable cardiac defibrillator
* Subjects with a heart transplant
* Female subjects who are currently taking hormone replacement therapy
* Subjects who are pregnant or planning on becoming pregnant
* Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)
18 Years
ALL
No
Sponsors
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NYHQ Cardiac Health Center
UNKNOWN
Pivotal Therapeutics
UNKNOWN
New York Hospital Queens
OTHER
Responsible Party
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Brian S. Marino, DO
Physician
Principal Investigators
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Brian S Marino, DO
Role: PRINCIPAL_INVESTIGATOR
New York Hospital Queens
Locations
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The NYHQ Cardiac Health Center
Fresh Meadows, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Albert CM, Campos H, Stampfer MJ, Ridker PM, Manson JE, Willett WC, Ma J. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med. 2002 Apr 11;346(15):1113-8. doi: 10.1056/NEJMoa012918.
Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
Bays H. Clinical overview of Omacor: a concentrated formulation of omega-3 polyunsaturated fatty acids. Am J Cardiol. 2006 Aug 21;98(4A):71i-76i. doi: 10.1016/j.amjcard.2005.12.029. Epub 2006 May 30.
Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. doi: 10.1093/ajcn/71.5.1085.
Grimsgaard S, Bonaa KH, Hansen JB, Nordoy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. doi: 10.1093/ajcn/66.3.649.
Geleijnse JM, Giltay EJ, Grobbee DE, Donders AR, Kok FJ. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. J Hypertens. 2002 Aug;20(8):1493-9. doi: 10.1097/00004872-200208000-00010.
Thies F, Garry JM, Yaqoob P, Rerkasem K, Williams J, Shearman CP, Gallagher PJ, Calder PC, Grimble RF. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet. 2003 Feb 8;361(9356):477-85. doi: 10.1016/S0140-6736(03)12468-3.
Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available.
Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
von Schacky C, Harris WS. Cardiovascular risk and the omega-3 index. J Cardiovasc Med (Hagerstown). 2007 Sep;8 Suppl 1:S46-9. doi: 10.2459/01.JCM.0000289273.87803.87.
Derosa G (2011) Effects of n-3 PUFA on Insulin Resistance After an Oral Fat Load. European Journal of Lipid Science. 113: (8) 950-960
Other Identifiers
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VCT-01
Identifier Type: -
Identifier Source: org_study_id
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